Myriad’s case is not a classic “patent troll” lawsuit since Myriad is using the patents at issue in its own diagnostic, BRACAnalysis®. The troll lawsuits typically entail third parties—some calling themselves “nonpracticing entities” or “patent intermediaries”—hired by inventors, companies, universities, investors, or others to engage rivals to stop their use of the IP involved. Third parties can play nice by working out licensing or sale deals, or play rough through lawsuits or threats to sue.
What Myriad’s new case signifies is a wave of biopharma court cases centered around “patent assertion”—a term neutral enough to be used by some trolls as a preferred term of art.
“There are going to be competitors out there that are going to want to challenge the IP of these companies. Competitors are going to be emboldened by the Supreme Court ruling, and I really think we are going to see more litigation on this as competitors want to test the breadth of the ruling,” James J. Mullen III, Ph.D., managing partner of the San Diego office of law firm Morrison & Foerster, told GEN.
Not that there’s anything wrong with that, he might have added: “A patent is a right to exclude people from practicing your invention. That right is only as good as your wherewithal to enforce those rights in court.”
In its new lawsuit, filed July 9, Myriad contends the Ambry and Gene by Gene tests infringe on patent claims for BRACAnalysis related to DNA primers and concrete method steps for genetic screening methods. Myriad owns five of the 10 patents, and licenses the rest from their owners, all co-plaintiffs in the new lawsuit: the University of Utah, University of Pennsylvania, Toronto’s Hospital for Sick Children, and Endorecherche.
The defendants insist they have done nothing wrong: “We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing and Ambry is fully committed to supporting our clients and patients moving forward,” Ambry CEO Charles Dunlop said in a July 10 statement.
It’s easy to see the commercial concerns behind the suit: Myriad wants to stop competitors from offering the test it says it spent $500 million to develop over 17 years. Myriad charges $3,340 for BRACAnalysis, which generated $115.4 million during the three months ending March 31, up 9% from a year earlier.
BRACAnalysis accounted for 74% of Myriad’s total revenue—no small consideration in the company’s playing hardball with rivals. GeneDx and Quest Diagnostics have launched their own BRCA tests. And as GEN reported last month, Pathway Genomics plans to launch its own BRCA test next month at what it calls a “substantially lower cost than the competition.”
“Myriad has suffered and will continue to suffer substantial damage to its business including, without limitation, lost profits, loss of business reputation, loss of business opportunities, and loss of market share,” the company asserted in its court complaint.
The Supreme Court enabled Myriad to play hardball by narrowing its decision to patentability of the seven genes at issue. The stringency of description requirements for biotech and pharma patents has insulated the industry from the extent of trolling cases in which software and e-commerce companies seek to monetize broadly written patents.
“You really have to describe exactly what you’re going after. And the patent office is not very generous with respect to the scope of the claims that they grant. It’s harder to get a patent to thing A, and then try to apply it to thing A-prime, which is what I see the patent trolls doing,” Dr. Mullen said.